Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

Summary

Hepatitis C Virus (HCV) infection is a global health problem. HCV mainly affects liver cells and causes the liver to become inflamed and damaged. This study will evaluate how safe and effective glecaprevir/pibrentasvir (GLE/PIB) is in adult and adolescent participants with acute HCV infection. GLE/PIB is an approved drug for the treatment of chronic HCV. Around 283 participants at least 12 years of age with acute HCV Infection will be enrolled in approximately 70 sites worldwide. Participants will receive oral tablets of GLE/PIB once daily (QD) for 8 weeks and will be followed for 12 weeks after the end of treatment. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, monitoring for side effects and completing questionnaires.

Official Title

A Multicenter, Single-Arm Prospective Study to Evaluate Safety and Efficacy of GLE/PIB 8-Week Treatment in Adults and Adolescents With Acute Hepatitis C Virus (HCV) Infection

Keywords

Hepatitis C Virus (HCV) Acute HCV Infection HCV Genotype 1-6 Hepatitis C Glecaprevir/Pibrentasvir ABT-493/ABT-530 Mavyret Infections Hepatitis A Hepatitis Glecaprevir/Pibrentasvir (GLE/PIB)

Eligibility

You can join if…

Open to people ages 12 years and up

  • Evidence of acute Hepatitis C Virus (HCV) infection prior to enrollment, defined as a physician diagnosis of acute HCV infection with at least 1 of the following:
  • Negative anti-HCV antibody, HCV Ribonucleic Acid (RNA) and/or HCV core antigen followed by a positive HCV RNA or HCV core antigen all within an 8-month period prior to screening; OR
  • Negative anti-HCV antibody, HCV RNA and/or HCV core antigen followed by a positive HCV RNA or HCV core antigen all within an 11-month period prior to screening; AND risk behavior for HCV infection within 6 months prior to positive HCV RNA or HCV core antigen; OR
  • Clinical signs and symptoms compatible with acute hepatitis [Alanine aminotransferase (ALT) > 5 × upper limit of normal (ULN) and/or jaundice] in the absence of a history of chronic liver disease or other cause of acute hepatitis and positive HCV RNA or HCV core antigen all within an 8-month period prior to screening; AND risk behavior for HCV infection within 6 months prior to positive HCV RNA or HCV core antigen; OR
  • Negative anti-HCV antibody with a positive HCV RNA or HCV core antigen within a 5-month period prior to screening.
  • Absence of hepatocellular carcinoma (HCC) for participants with cirrhosis as indicated by a negative ultrasound, computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to screening or a negative ultrasound at screening. Participant who has a positive ultrasound result suspicious of HCC followed by a subsequent negative CT scan or MRI or biopsy result will be eligible for the study.
  • Participants documented as having no cirrhosis or as having compensated cirrhosis.

You CAN'T join if...

  • Participants with prior treatment, including interferon for this HCV infection.
  • History of liver decompensation.

Locations

  • University of California, Davis Comprehensive Cancer Center /ID# 230814 accepting new patients
    Sacramento California 95817 United States
  • TLC Clinical Research Inc /ID# 232334 accepting new patients
    Los Angeles California 90048 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses. Sign up for this study
ID
NCT04903626
Phase
Phase 3 Hepatitis C Research Study
Study Type
Interventional
Participants
Expecting 283 study participants
Last Updated